A Randomised Clinical Trial Comparing Two Biopsy Templates and Follow-up Schedules for Men on Active Surveillance for Low-risk Prostate Cancer: SAMS.

Background and objective: Neither the number nor location of biopsy cores or follow-up schedules for active surveillance of prostate cancer are based on evidence from randomised trials. We therefore initiated a study that compared two follow-up schedules in this setting. The main endpoint was decision to initiate curative treatment within 5 yr from randomisation. Methods: Men aged 40-75 yr with low-risk prostate cancer (grade group 1, T1c/T2a, ≤33% positive biopsy cores, prostate-specific antigen [PSA] ≤13 μg/l, PSA density ≤0.2 μg/l/cm Key findings and limitations: Data for 328 men were available for analysis. After 5 yr, 42% in the standard arm and 36% in the experimental arm received treatment with curative intent ( Conclusions and clinical implications: Use of an extended confirmatory biopsy may allow for less intensive surveillance of low-risk prostate cancer in a setting without routine use of MRI. This approach has the potential to reduce the burden of repeat biopsies without compromising the effectiveness of disease monitoring. Patient summary: For men with low-risk prostate cancer, use of a more extensive initial biopsy followed by less intensive monitoring resulted in similar 5-year treatment rates as for standard monitoring. This suggests that follow-up with fewer scheduled biopsies can be considered without affecting the overall quality of surveillance when MRI (magnetic resonance imaging) is not available.